A phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral ladarixin in patients with new-onset type 1 diabetes and a low residual β-cell function at baseline.

This Study is
No Longer Enrolling

Description

A phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral ladarixin in patients with new-onset type 1 diabetes and a low residual β-cell function at baseline. It has been designed to further evaluate whether ladarixin is effective in preserving β-cell function and slowing down the progression of type 1 diabetes (T1D) in patients with a more severe disease presentation.

Details
Age

Child to Adult

Eligibility

Age 14-45 years, within 100 days of type 1 diabetes diagnosis

Ages 14-45, diagnosed with T1D, within 100 days of first insulin administration, currently using insulin therapy, positive for 1 or more T1D auto-antibodies, no other chronic illnesses, otherwise healthy, not pregnant or breastfeeding.

Type of Study

Treatment

Locations

Barbara Davis Center
University of Colorado Hospital

Study ID

Protocol Number: 21-2474

More information available at ClinicalTrials.gov: NCT04628481

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